BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEC 7

    MDR report key: 19030959 · Received April 3, 2024

    Report

    Report Number
    2112667-2024-01782
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 5, 2024
    Report Date
    May 10, 2024
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    PMA / PMN Number
    K031027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE HAS INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO REPAIR INFORMATION AVAILABLE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR THAT ERRONEOUSLY GAVE H6 CLINICAL CODE E013403 - NERVOUS SYSTEM - TACTILE DISORDERS - PARESTHESIA. THE CORRECT CODE IS E2403 - OTHERS - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AGENT DELIVERED GREATER THAN 30% FROM SETTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784170 TEC 7 VAPORIZER CAD DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown